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Biocidal product factsheet - Last updated: 26/02/2024

Biocidal Product details

Trade name:

Ben's 30

Ben's 30 kullancs- és szúnyogriaszó aeroszol (pumpás)

Ben's Insect Repellent

Ben's Repell

Ben‘s 30

REPEL BITE XTREME

Εντομοαπωθητικό Ben’s

Product-type:

PT19

Active Substance details

Substance name:

N,N-diethyl-meta-toluamide

IUPAC name:

N,N-diethyl-m-toluamide

EC number:

205-149-7

CAS number:

134-62-3

BAS number:

Authorised

Expired

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

11 authorisations in the product cluster

Trade name	Product-type	Market area	Authorisation holder	Authorisation number		Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Trade name	Product-type	Market area	Authorisation holder	R4BP 3 asset	National	Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Ben's Insect Repellent	PT19	United Kingdom	Ardern Healthcare Limited	R4BP 3 asset	National	UK-0008929-0000	UK-2016-1008	01/08/2016	31/12/2020	SPC not available	Expired
Εντομοαπωθητικό Ben’s	PT19	Cyprus	Laboratorio Chimico Farmaceutico A.Sella srl	CY-0016695-0000	ΚΥ-0073	01/08/2016	26/07/2026	Single SPC (el)	Bens insect repellent_auth.pdf (el) (20/03/2017) Bens Insect Repellent_MIC.pdf (el) ΚΥ-0073_Εντομοαπωθητικό Ben's.pdf (el)	Authorised
Ben's 30	PT19	Estonia	Laboratorio Chimico Farmaceutico A.Sella srl	EE-0011394-0000	EE-NAMR2017-0083	01/08/2016	26/07/2026	Jezik Single SPC (en) Single SPC (et)	EE-NAMR2017-0083_Ben's 30.pdf (et) (12/04/2017) NA-TRS otsus Ben's Insect Repellent.pdf (et) NA-MIC rMS loa muutus Ben_s Insect Repellent 21.09.2020.pdf (et)	Authorised
Ben's 30 kullancs- és szúnyogriaszó aeroszol (pumpás)	PT19	Hungary	Laboratorio Chimico Farmaceutico A.Sella srl	HU-0011371-0000	HU-2017-MA-19-00180-0000	01/08/2016	26/07/2026	Single SPC (hu)	9876-17-2020-KBKHF_Bens 30 kullancs �s sz�nyogriaszt� aeroszol_authorisation.pdf (hu) Decision regarding the transfer of Ben's kullancs- es szunyogriaszto aeroszol (pumpas).pdf (hu)	Authorised
Ben's 30 Ben's Insect Repellent	PT19	Ireland	Laboratorio Chimico Farmaceutico A.Sella srl	IE-0011547-0000	IE/BPA 70334	01/08/2016	26/07/2026	Single SPC (en)	IE-BPA 70334 Authorisation Cert Ver1.2.pdf (en)	Authorised
Ben's Repell	PT19	Italy	Laboratorio Chimico Farmaceutico A.Sella srl	IT-0022149-0000	it/2019/00594/mrs	01/08/2016	26/07/2026	Single SPC (it)	ben's repell.pdf (it) BC-ND061005-58_Ben's Repell.pdf (it)	Authorised
Ben's 30	PT19	Latvia	Laboratorio Chimico Farmaceutico A.Sella srl	LV-0010624-0000	LV/2017/MR/005	01/08/2016	26/07/2026	Single SPC (lv)		Authorised
Ben‘s 30	PT19	Lithuania	Laboratorio Chimico Farmaceutico A.Sella srl	LT-0011503-0000	(10-14 17.5)BSV-2104(A-19BAP911848/A-19-24)	17/02/2017	26/07/2026	Single SPC (lt)	Bens 30 MIC 2021 lydrastis.pdf (en) 1848 Bens 30 su bsv.doc (lt) 1848 A Authorisation Bens 30 2019.pdf (lt)	Authorised
Ben's Insect Repellent	PT19	Netherlands	Laboratorio Chimico Farmaceutico A.Sella srl	NL-0018740-0000	-	03/08/2016	26/07/2026	Single SPC (nl)	20172236_NL-0018740-0000_Authorisation.doc (nl) 20190723_nl_0018740_0000_administrative_change.pdf (nl) 20201006_nl_0018740_0000_minor change.docx (nl)	Authorised
Ben's Insect Repellent	PT19	Slovenia	Laboratorio Chimico Farmaceutico A.Sella srl	SI-0011344-0000	SI-0011344-0000	01/08/2016	26/07/2026	Single SPC (sl)	Laboratorio_Chimico__Ben_s_Insect_Re_P.pdf (sl) Laboratorio_Chimico__Ben_s_Insect_re_P.pdf (sl) Laboratorio_Chimico__Ben_s_Insect_R_P.pdf (sl)	Authorised
REPEL BITE XTREME	PT19	Spain	ESTEVE PHARMACEUTICALS, S.A.	ES-0009003-0000	ES/MR(NA)-2016-19-00391	01/08/2016	26/07/2026	Single SPC (en)	00391 Repel Bite Xtreme.pdf (es) (19/01/2017) R4BP-ES-0009003-0000-Authorisation.pdf (es)	Authorised

Reference authorisation

Trade name: Ben's Insect Repellent
Authorisation number: UK-0008929-0000| Market area: United Kingdom

5 assessment records available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

16/12/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

National authorisation minor change on request

Evaluating authority:

United Kingdom

Conclusion date:

15/12/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

11/12/2018

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

12/01/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Application of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

01/08/2016

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition

Trade name: Εντομοαπωθητικό Ben’s
Authorisation number: CY-0016695-0000| Market area: Cyprus

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Cyprus

Conclusion date:

12/07/2022

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (el)

Transfer of a national authorisation

Evaluating authority:

Cyprus

Conclusion date:

29/03/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in sequence

Evaluating authority:

Cyprus

Conclusion date:

20/03/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's 30
Authorisation number: EE-0011394-0000| Market area: Estonia

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Estonia

Conclusion date:

21/09/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Jezik

Single SPC (et)

Transfer of a national authorisation

Evaluating authority:

Estonia

Conclusion date:

17/12/2018

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Estonia

Conclusion date:

12/04/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's 30 kullancs- és szúnyogriaszó aeroszol (pumpás)
Authorisation number: HU-0011371-0000| Market area: Hungary

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Hungary

Conclusion date:

03/12/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (hu)

Transfer of a national authorisation

Evaluating authority:

Hungary

Conclusion date:

29/08/2018

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Hungary

Conclusion date:

10/02/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's 30 , Ben's Insect Repellent
Authorisation number: IE-0011547-0000| Market area: Ireland

6 assessment records available

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

15/12/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (en)

National authorisation minor change on request

Evaluating authority:

Ireland

Conclusion date:

25/09/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

07/08/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Transfer of a national authorisation

Evaluating authority:

Ireland

Conclusion date:

19/02/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

25/10/2018

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Ireland

Conclusion date:

17/08/2016

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's Repell
Authorisation number: IT-0022149-0000| Market area: Italy

2 assessment records available

National authorisation minor change on request

Evaluating authority:

Italy

Conclusion date:

22/07/2022

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (it)

Mutual recognition in sequence

Evaluating authority:

Italy

Conclusion date:

23/01/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's 30
Authorisation number: LV-0010624-0000| Market area: Latvia

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Latvia

Conclusion date:

14/10/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (lv)

Transfer of a national authorisation

Evaluating authority:

Latvia

Conclusion date:

27/11/2018

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Latvia

Conclusion date:

25/01/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben‘s 30
Authorisation number: LT-0011503-0000| Market area: Lithuania

4 assessment records available

National authorisation minor change on request

Evaluating authority:

Lithuania

Conclusion date:

25/02/2021

Validity of authorisation

Start date:

17/02/2017

End date:

26/07/2026

SPC

Single SPC (lt)

Transfer of a national authorisation

Evaluating authority:

Lithuania

Conclusion date:

01/02/2019

Validity of authorisation

Start date:

17/02/2017

End date:

26/07/2026

SPC

SPC not available

Amendment of national authorisation

Evaluating authority:

Lithuania

Conclusion date:

12/11/2018

Validity of authorisation

Start date:

17/02/2017

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Lithuania

Conclusion date:

22/02/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's Insect Repellent
Authorisation number: NL-0018740-0000| Market area: Netherlands

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Netherlands

Conclusion date:

08/10/2020

Validity of authorisation

Start date:

03/08/2016

End date:

26/07/2026

SPC

Single SPC (nl)

Transfer of a national authorisation

Evaluating authority:

Netherlands

Conclusion date:

23/07/2019

Validity of authorisation

Start date:

03/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in sequence

Evaluating authority:

Netherlands

Conclusion date:

01/08/2018

Validity of authorisation

Start date:

03/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's Insect Repellent
Authorisation number: SI-0011344-0000| Market area: Slovenia

4 assessment records available

National authorisation minor change on request

Evaluating authority:

Slovenia

Conclusion date:

24/09/2020

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (sl)

Amendment of national authorisation

Evaluating authority:

Slovenia

Conclusion date:

26/03/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Transfer of a national authorisation

Evaluating authority:

Slovenia

Conclusion date:

21/03/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Slovenia

Conclusion date:

26/05/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: REPEL BITE XTREME
Authorisation number: ES-0009003-0000| Market area: Spain

3 assessment records available

National authorisation administrative change on request

Evaluating authority:

Spain

Conclusion date:

21/01/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC (en)

National authorisation administrative change on request

Evaluating authority:

Spain

Conclusion date:

21/01/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Spain

Conclusion date:

19/01/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available